SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment. Hailu Tegegnework and Fikadu Deme

Transcription

1 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Hailu Tegegnework and Fikadu Deme August 24

2 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment This technical report is made possible by the generous support of the American people through the US Agency for International Development (USAID), under the terms of cooperative agreement number AID-OAA-A--2. The contents are the responsibility of Management Sciences for Health and do not necessarily reflect the views of USAID or the United States Government. About SIAPS The goal of the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program is to assure the availability of quality pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes. Toward this end, the SIAPS result areas include improving governance, building capacity for pharmaceutical management and services, addressing information needed for decision-making in the pharmaceutical sector, strengthening financing strategies and mechanisms to improve access to medicines, and increasing quality pharmaceutical services. Recommended Citation This report may be reproduced if credit is given to SIAPS. Please use the following citation: Hailu Tegegnework and Fikadu Deme. 24. Antimalaria Drugs Management, Baseline Assessment Report, USAID/SIAPS/PMI Ethiopia, August, 24. Submitted to the US Agency for International Development by the Strengthening Pharmaceutical Systems Program. Arlington, VA: Management Sciences for Health. Key Words Ethiopia, AMDM/PMI, baseline assessment, summary findings Systems for Improved Access to Pharmaceuticals and Services Center for Pharmaceutical Management Management Sciences for Health 43 North Fairfax Drive, Suite 4 Arlington, VA 2223 USA Telephone: Fax: siaps@msh.org Website: ii

3 CONTENTS Acronyms... iv Introduction... Malaria in Ethiopia... Methodology... 2 Scope and Objective... 2 Sample Sites... 2 Assessment Teams and Training... 3 Assessment Tools and Informants... 3 Limitations... 3 Survey Findings and Analysis... 5 General Assessment and Targets... 5 Malaria Diagnosis in s and s... 7 Availability of the National Malaria Diagnosis and Treatment Strategy and National Malaria Diagnosis and Treatment Guidelines... 8 Availability and Use of Standard Prescription Forms... 9 Prevalence of Malaria Parasite Species... Knowledge of Providers... 4 Product Availability... 5 Stock-Out Days for AMDs... 6 Expiry of Malaria Medicines in Assessed HFs... 6 Stock-Out Days for Antiretroviral Drugs at HFs... 7 Laboratory Commodities Availability... 9 Storage and Store Accessories... 9 Pharmaceutical Management Information System (PMIS) Conclusion and Recommendations Availability and Expiry Management Storage, Inventory Control, and Pharmaceutical Management Information System Human Capacity and Knowledge... 3 Other Issues... 3 iii

4 ACRONYMS ACT AL AMD AMDM ARV CDC DHO E.C. FMOH HF IPD IPTp IRS ITN LMIS mg MOH MOP MSH NMDTG NMDTS OI OPD PF PM PMI PMIS PO PSMS PV RDT RHB RHZE RTA SIAPS SNNPR SP SPS ZHD Artemisinin-based combination therapy Artemether-lumefantrine Antimalarial drug Antimalaria drugs management Antiretroviral US Centers for Disease Control and Prevention District health office Ethiopian calendar Federal Ministry of Health Health center Health facility Inpatient department Intermittent preventive treatment of malaria in pregnancy Indoor residual spraying Insecticide-treated net Logistics management information system milligram Ministry of Health Malaria operational plan Management Sciences for Health National Malaria Diagnosis and Treatment Guidelines National Malaria Diagnosis and Treatment Strategy Opportunistic infection Outpatient department Plasmodium falciparum Plasmodium malariae President s Malaria Initiative Pharmaceutical management information system Plasmodium ovale Pharmaceutical supply management system Plasmodium vivax Rapid diagnostic test Regional health bureau Rifampicin + isoniazid + pyrazinamide + ethambutol Regional technical advisor Systems for Improved Access to Pharmaceuticals and Services Southern Nations, Nationalities and Peoples Regional State Sulfadoxine-pyrimethamine Strengthening Pharmaceutical Systems Zonal health department iv

5 INTRODUCTION The President s Malaria Initiative (PMI) is an interagency initiative led by the US Agency for International Development (USAID) with the US Centers for Disease Control and Prevention (CDC). PMI aims to reduce malaria-related mortality by 5% in 5 countries in sub-saharan Africa by 2. It plans to meet this goal by achieving 85% coverage of the most vulnerable groups children under 5, pregnant women, and people living with HIV and AIDS using proven preventive and therapeutic interventions, including artemisinin-based combination therapies (ACTs), insecticide-treated nets (ITNs), intermittent preventive treatment of malaria in pregnancy (IPTp), and indoor residual spraying (IRS). Malaria in Ethiopia Malaria is one of the leading communicable diseases in Ethiopia. Almost 75% of Ethiopia s land mass is malarious, whereby 68% of the population is at risk of contracting malaria. Furthermore, 6% of malaria cases are caused by Plasmodium falciparum (PF) and 4% by Plasmodium vivax (PV). In most parts of Ethiopia, the transmission of malaria is largely unstable in character and seasonal because of the altitude and climatic factors. In October 26, Ethiopia was selected as a focus country for PMI. The PMI resources allocated to Ethiopia target the Oromia Regional State, the country s largest administrative region and the one bearing the brunt of the country s malaria burden. Overall systems support that is provided will benefit central management at the federal Ministry of Health (FMOH) and in the other regions. In 27, the Ethiopia Malaria Operational Plan (MOP), which outlines activities to be supported by PMI, identified Strengthening Pharmaceutical Systems (SPS)/Management Sciences for Health (MSH) as its partner for providing technical assistance and support to PMI regarding antimalaria drugs management (AMDM). In 22, Systems for Improved Access to Pharmaceuticals and Services (SIAPS), a successor of SPS implemented by MSH, continued to implement the AMDM activities to ensure the availability of high-quality pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes. To that end, the SIAPS areas of focus include improving governance, building capacity for pharmaceutical management and services, addressing information needed for decision-making in the pharmaceutical sector, strengthening financing strategies and mechanisms to improve access to medicines, and increasing high-quality pharmaceutical services.

6 METHODOLOGY Scope and Objective This is a focused, rapid, participatory, and comprehensive baseline assessment, intended to gather operational information for the purpose of identifying immediate gaps and undertaking appropriate interventions. Sample Sites All selected sites were assessed except Gambella Region health facilities (HFs), from which data was not collected due to security problems in that area during the assessment period. USAID/PMI selected the sites and the PMI/AMDM office conducted the mapping of the assessment locations. The assessment target areas included the following: s and health centers (s) = 76 HFs (with their respective laboratories and pharmacy units) Regional, zonal, and district health offices Sites were selected from all regions of the country except Oromia region. Figure. Assessment map 2

7 Methodology Assessment Teams and Training SIAPS regional technical advisors (RTAs) conducted the assessment, and the respondents of the assessment were staff members from the Regional Health Bureau (RHB), District Health Office (DHO) and health facility personnel. A training and orientation program was organized for the data collection team on the AMDM assessment. The training focused on the national and international incidence of malaria, the purpose of the assessment, the assessment questionnaires, and how to conduct the assessment. Assessment Tools and Informants Three structured questionnaires were used to collect the baseline assessment. The assessment tools included both qualitative and quantitative questions. The respondents were pharmacists, laboratory personnel, prescribers from HFs, and personnel representing the supply sector from RHBs, Zonal Health Departments (ZHDs), and DHOs. Limitations The baseline assessment did not contain a pre-test of the questionnaires, but they were discussed with the RTAs, who were familiar with the questionnaires. The sample sites were not statistically selected but chosen based on prevalence and representation of intervention targets. The assessment is not designed to be a scientific study but a guide for intervention planning. Five HFs (one hospital and four s) in Gambella Region were not assessed due to the security problems at the time of the assessment. Quantitative data such as the number of malaria cases tested and cases treated were not complete due to the weak recording systems at the HFs assessed. 3

8 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Table. Topics Covered in the Questionnaires Parameters Providers` knowledge status Training status Availability of malaria treatment guidelines Availability and expiry of malaria, tuberculosis (TB), and HIV/ opportunistic infection (OI) medicines and of laboratory reagents and commodities Storage status Disposal status Logistics management information system (LMIS) and reporting status Explanations The questionnaire to providers (e.g., physicians, health officers, nurses, and pharmacy personnel) contained questions regarding malaria diagnosis and treatment, and other issues. The responses obtained were compared with the correct answers as indicated in the National Malaria Diagnosis and Treatment Guideline. The interviewees were asked whether they had received training on the new malaria treatment guidelines. The respondents were asked if they have received guidelines (i.e., the National Malaria Strategy Manual and the National Malaria Diagnosis and Treatment Guideline). On the day of the assessment visit, the data collectors went into the drug stores, dispensary areas, and laboratories to check the availability of important key tracer medicines and laboratory products. They also checked for the presence of expired products and asked for how long they had had stock-outs. Proper storage was assessed through direct observations on such factors as cleanliness, how stocks were arranged, labeling, the existence of adequate space, and the availability of shelves and pallets. The responses show the percentage of facilities with the indicated variables. Disposal status was assessed by checking such factors as the presence of expired or damaged products, quantity of the expired stock, and whether expired or damaged items are stored separately from active stock. The responses show the percentage of facilities that claimed to have disposed of expired, obsolete, or damaged products. The assessment examined the presence and use of stock cards, bin cards, treatment registers, and computers, including reporting their status to higher levels. The responses show the percentage of facilities that respond whether they have the elements assessed. 4

9 SURVEY FINDINGS AND ANALYSIS General Assessment and Targets The general questions about health services were designed to obtain information on the types of facilities, the services they provide, staffing, testing results, morbidity, and treatment through interviews and document reviews at the facility level. In total, 4 public health service units from all PMI/AMDM new expansion regions except Gambella were included in the assessment (table 2 and figure ). Of those, the greatest number, 37%, were in the Amhara region and the lowest, 2%, were in the Harari region. The health service units surveyed included 72 (5%) that were ZHDs and DHOs, while 69 (49%) were HFs, including hospitals and s. Table 2. Survey Area Region DHO ZHD Total Percentage Tigray Harari Dire Dawa Afar Amhara Somali Benishangul-Gumuz Southern Nations, Nationalities, and Peoples Regional State (SNNPR) Total In total, 24 health service providers were included in the assessment, as shown in table 3. The breakdown is as follows 69 (34%) were in clinical practice medical doctors, health officers, and nurses 67 (33%) were pharmacy professionals pharmacists, druggists, and pharmacy technicians and nurses assigned to a pharmacy practice 68 (33%) were laboratory professionals laboratory technologists and technicians 5

10 Pharmacist Pharmacy Technician Druggist Nurse Health Officer Internist Medical Director Nurse Laboratory Technician Laboratory Technologist SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Table 3. Number and Professional Category of Providers Interviewed Pharmacy Professionals Prescribers Laboratory Staffs Region Tigray Harari 2 Dire Dawa Afar Amhara Somali Benshangul-Gumuz SNNPR Total All hospitals and s are expected to have outpatient departments (OPDs) and inpatient departments (IPDs) that provide outpatient and inpatient (i.e., admitted patient) services (table 4). Table 4. Availability of Selected Services Indicators Does the facility have an OPD? Does the facility have an IPD? Does the facility have a pharmacy unit with a dispensary? Does the facility have a counseling area? Does the facility have a separate store? Is the DHO located in the facility? Does the facility drug store also serve as the district drug store? Are HIV, OI, malaria, and TB drugs stored in the same store? Type of HF and % and % Yes 23 % 46 % No Yes 22 96% 38 83% No 8 Yes 23 % 44 96% No 2 4% Yes 8 36% 6 35% No 4 64% 3 65% Yes 3 59% 24 52% No 9 4% 22 48% Yes % 3 3% No 9 95% 3 68% NA 5% 2% Yes 2 67% 9 2% NA 33% 2% Yes 6 73% 43 93% No 6 7% 3 7% 6

11 Survey Findings and Analysis Health service facilities comprised of 23 hospitals and 46 s were asked about the type of patient and pharmacy services they provide. Important observations made include the following: All of the hospitals and s are functional in that they all have an OPD unit while almost all (96%) of the hospitals and most of the s (83%) operate an inpatient unit. All of the hospitals and 96% of the s have a pharmacy unit with a dispensary while only 36% of the hospitals and 35% of the s have a medicine counselling area for patients. The availability of storage space for medicines is limited both at the s (52%) and at the hospitals (59%). About 3% of the DHOs are located in the same compound as the s and 2% of the s share their store with DHOs. On the other hand, about three-quarters of the hospitals (73%) and 93% of the s have HIV, OI, malaria and TB drugs stored in the same store. Malaria Diagnosis in s and s The current (June 24) National Malaria Diagnosis and Treatment Guidelines recommend that malaria treatments in all clinically suspected cases should be based on a laboratory diagnosis for the parasite species using a microscopic method at hospitals and s and rapid diagnostic test (RDT) diagnosis at the health-post level. Thus, the assessment included questions about the percentage of suspected malaria cases the clinicians sent to the laboratory for microscopic confirmation. The findings included the following: About 7% of prescribers at hospitals and more than 8% of prescribers at s always send clinically suspected malaria cases for testing. Only 7% of prescribers in hospitals and % in s stated that they asked for laboratory diagnosis for fewer than 75% of their patients. Although this appears to be a strong indication of adherence to the guidelines, the findings also show there are prescribers who need to show improvement with regard to sending all suspected cases for laboratory confirmation. Table 5. Percentage of Prescribers Who Send Suspected Malaria Cases for Microscopy Testing Total Sent for Laboratory Confirmation % of the Time 75 99% of the Time <75% of the Time Total Count % 69.6% 3.% 7.4%.% Count % 8.4% 8.7%.9%.% Count % 76.8%.% 3.%.% 7

12 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Sent for Lab. Confirmation <75% of the time Sent for Lab. Confirmation 75-99% of the Time Sent for Lab. Confirmation % of the Time Health Center (n=46) (n=23) Figure 2. Percentage of prescribers who send suspected malaria cases for microscopy testing Availability of the National Malaria Diagnosis and Treatment Strategy and National Malaria Diagnosis and Treatment Guidelines The FMOH produced the National Malaria Diagnosis and Treatment Strategy (NMDTS) and the National Malaria Diagnosis and Treatment Guidelines (NMDTG), which are based on the national prevailing disease conditions and the malaria parasite susceptibility to existing drugs. For better adherence, health providers at the different levels should be trained to implement the current guidelines. In the assessment, we sought to determine the availability of the guidelines at the different service areas and categories (prescribers, dispensers, and program coordinators at zonal and district levels), and if trainings have been provided on malaria case managements based on the current guidelines. The results are shown in tables 6 and 7. Table 6. FMOH Malaria Diagnosis and Treatment Guidelines Availability and Training in Malaria Drugs Management (Dispensers) Dispensers Are the FMOH Malaria Diagnosis and Treatment Guidelines Available? (n=68) Trained in Malaria Drugs Management? (n=69) Yes No Yes No.5% 3.9% 33.3% 7.4% 6.3%.4% 65.2% Total 8.8% 9.2%.4% 98.6% 8

13 Survey Findings and Analysis Table 7. FMOH Malaria Diagnosis and Treatment Guidelines Availability and Training in Malaria Drugs Management (at Prescribers Level) Prescribers Are the FMOH Malaria Diagnosis and Treatment Guidelines Available? (n=67) Received Refresher Training on Malaria Case Management? (n=69) Yes No Yes No 9.% 25.4% 4.3% 29.%.9% 53.7%.% 56.5% Total 2.9% 79.% 4.5% 85.5% Table 8. FMOH Malaria Prevention and Control Strategy Documents Availability and Refresher Training in Malaria Drugs Management Organization Are the FMOH Malaria Prevention and Control Strategy Documents Available? Are the FMOH Malaria Diagnosis and Treatment Guidelines Available? Received Refresher Training in Malaria Drugs Management? Yes No Yes No Yes No (n=23).5% 3.9% % 33.3% (n=46) 7.4% 6.2%.4% 65.3% DHO (n=52) 26.9% 73.% 43.% 56.9% 26% 74% ZHD (n=9) 42.% 57.9% 77.8% 22.2% 5.8% 84.2% The overall availability of the NMDTG is significantly lower only 2.9% at the prescribers level and 8.8% at the dispensers level at hospitals and s. Although the availability of both the Malaria Control Strategy document and the NMDTG at ZHDs (42.%) and DHOs (26.9%) is not satisfactory, they are higher percentages than those at the HFs. Similarly, the NMDTG is more available at the coordination offices 77.8% at ZHDs and 43.% at the DHOs. In short, the NMDTG should have been the daily reference handbook for the staffs that are actually conducting the routine diagnosis, treatment, and dispensing practices. Concerning trainings conducted on the types of services provided, 85.5% of prescribers said they have not received trainings in malaria case management while 98.6% of the dispensers said they have not received trainings in the management of malaria drugs management. Further, 74% of respondents from DHOs and 84.2% from ZHDs also have not received trainings in malaria drugs management Availability and Use of Standard Prescription Forms Prescriptions are basic documents specifying the prescribers` intentions regarding the drug order for a patient that the dispenser should fill accordingly. In addition to being a means of clear communication between the prescriber and dispenser, they are also legal documents showing the type and quantity of drugs provided to the patient. The questionnaire also sought information on the availability of the prescription paper and its proper use both at the facility and region levels. 9

14 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Table 9. Comparative Availability of Standard Prescriptions at s and s Facilities Having a Standard prescription Paper Type of HF Total Yes 6 (69.6%) 2 (26%) 28 No 7 (3.4%) 34 (74%) 4 Total Table. Availability and Use of Standard Prescription Forms at s and s in Each Region Region of the Health Facility Tigray Harari Dire Dawa Afar Amhara Somali Benshangul- Gumuz SNNPR Have a Standard Prescription Paper? Does the Prescriber Always Enter Full Information on the Prescription? Yes No Yes No Total 28 (4.5%) 4 (59.4%) Below are some of the findings at the HFs and overall regional levels: While 69.6% of the hospitals responded that they have standard prescription papers, only 26% of s said they have standard prescription papers. Findings by region show that 59.4% of the health service facilities (both hospitals and s) do not have standard prescription papers. Almost all of the facilities in the different regions also responded that the prescribers do not always enter full information in their prescriptions. The absence of standard prescriptions containing all patient and drug use information will hinder the proper documentation of existing pharmaceutical management information system (PMIS) tools. This will also impact follow-up regarding rational use of medicines, especially with respect to prescribing and dispensing antimalaria drugs (AMDs) where only specific drugs are indicated for certain malaria species and contraindicated in certain age groups and presence of pregnancy.

15 Survey Findings and Analysis Prevalence of Malaria Parasite Species According to the data collected on the number of patients who were examined and tested positive for malaria at selected hospitals and s in 22 and 23 Ethiopian Calendar (E.C.), Amhara and SNNPR are the regions with the highest number of patients treated while Somali and Diredawa are the regions with the lowest. Amhara region treated 99,76 and 68,99 malaria patients in 22 and 23 E.C., respectively, while Somali region treated four and two malaria patients in those two years at the target facilities included in the data collection. The number of positive cases for adults and children under five years of age is significantly greatest in SNNPR and Amhara while Diredawa and Somali have the fewest. Table : Number of Patients Who Were Examined and Tested Positive for Malaria at Selected s and s in 22 and 23 E.C. (Equivalent to 2 and 2) 22 E.C. 23 E.C. Region of the HF Total Treated Adult (>5 Years) <5 Years Total Treated Adult (>5 Years) <5 Years Tigray 45,2 27,392 5,572 42,7 29,352 6,267 Harari Dire Dawa Afar 3,2,6 2,764 7,38 2,254 3,45 Amhara 99,76 52,2 5,95 68,99 42,862 2,976 Somali Benshangul- Gumuz,862, ,4 4, SNNPR 77,84 65,765 6,982 73,643 6,434 7,88 Grand Total 247,46 56,582 4,792 24,42 5,546 4,342 Prescribers (n=68) were asked to identify the types of prevalent malaria parasites they encounter in their clinical practice (table 2). These findings are not based on any document review. Table 2. Prescribers Responses on Types of Malaria Parasites Encountered Type of Malaria Parasites Frequency % Mixed.5% PV % PF % Total 68.% The responses we received show that the highest prevalence of malaria parasites that the prescribers manage is PF (69.%), followed by PV (29.4%) and mixed cases (just over %). The prevalence of Plasmodium malariae (PM) and Plasmodium ovale (PO) appears to be rare in the surveyed regions of the country. The responses we received from the prescribers (table 2) do not support the findings from a records review we conducted (table 3), where about 38,874 malaria-confirmed persons treated in 5 HFs (5 hospitals and s) showed an average of 6.4% PF, 38.4% PV, and

16 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment.3% mixed in 22. In 23 E.C., on the other hand, 24,954 malaria-confirmed persons were treated and 49.5%, 49.8%, and.7% were PF, PV, and mixed, respectively. The data in 22 is approximately consistent with the national PF/PV ratio, which is reported to be 6% for PF and 4% for PV. However, in 23 an almost equal number of PF and PV cases were treated at these HFs, indicating an instability of the proportion, which may have an impact on the type of medicines supplied to treat patients. As shown in tables 3 and 4 below, the total number of cases treated (94,229 in 22 and 64,255 in 23 E.C.) is greater than the total number of confirmed cases (38,874 in 22 and 24,954 in 23 E.C.). This may be attributable to either poor record keeping or treatment of patients without laboratory confirmation (59% in 22 and 6% in 23 E.C.). The large gaps in the findings indicate a need to improve data quality and look at the capacity of laboratories to make species differentiation accurately and consistently, as well as ensure that all patients are diagnosed before they receive treatment for malaria. Table 3. Malaria Prevalence Findings from Records Review at Targeted HFs in 22 E.C. Name of HF Total Treated PF Total PV Total Mixed Total Adare 5,76 2,26 2,97 74 Addis Zemen Health Center 8,29 5,965,455 4 Aleta Wondo Town Health Center Assosa, Bati Health Center Dangila Health Center, Dil Chora 6 5 Harbu Health Center 5,46 2,26 3,254 Jijiga Health Center 4 4 Koladiba Health Center 25,94 4,78,67 89 Kombolcha Health Center National 2, Wolkite Health Center 2,775,73,23 2 Woreta Health Center 26,647 5,362 2,252 8 Yergalem 2, Grand Total 94,229 23,47 4, Table 4. Malaria Prevalence Findings From Records Review at Targeted HFs in 23 E.C. Name of HF Total Treated PF Total PV Total Mixed Total Adare 2, , Aleta Wondo Town Health Center,92 237,222 4 Assosa Health Center, Bati Health Center, Dangila Health Center,275 2,64 Dil Chora Dilla Town Health Center 7,797,776,4 5 Haike Health Center, Harbu Health Center,485 54,33 Jijiga Health Center 2 Koladiba Health Center,686,55,23 24 Legehare Health Center

17 Survey Findings and Analysis Name of HF Total Treated PF Total PV Total Mixed Total Melkawerer Health Center,982 3,435,54 2 Metema 4,89 2, National, Wolkite Health Center 2,775,424, Yergalem 2, Grand Total 64,255 2,355 2,43 69 Table 5 shows the regional malaria parasites prevalence and proportion of clinical malaria treatment based on data collected from targeted HFs. Somali (%), Diredawa (83%), and Amhara (7%) are the regions where the PF malaria species is the most prevalent, while Benishangul-Gumuz (8%) and Harari (72%) are the regions where PV malaria exists more. Although there are no cases of PO malaria in other regions, a few cases (.2%) have been reported in Amhara. According to the report, the proportion of mixed malaria cases is very low in all regions except Tigray, where a significant number of cases (63%) were reported. On the other hand, Benshangul-Gumuz (9%), Tigray (86%), Amhara (67%), and Afar (5%) contain a substantially higher number of malaria patients treated without laboratory confirmation while Somali (%), Diredawa (%) and Harari (%) contain the fewest. SNNPR treated 23% of those with malaria without laboratory confirmation. This practice of treating malaria patients without laboratory confirmation will have a negative impact both on the quality of treatment and availability of specific antimalarial drugs. Table 5. Regional Malaria Parasites Prevalence and Proportion of Clinical Malaria Treatment Findings From Records Review at Targeted HFs in 22 E.C. Region of HF Total Treated PF Total PV Total PM Total Mixed Total Clinically Treated Tigray Sum 45,2 2, ,2 38,63 N % 35% 2% % 63% 86% Harari Sum N 2 % 28% 72% % % % Dire Dawa Sum 6 5 N % 83% 7% % % % Afar Sum 3,2 4,944,53 7 6,538 N % 76% 23% % % 5% Amhara Sum 99,76 23,229 9, ,55 N % 7% 29% % % 67% Somali Sum 4 4 N % % % % % % 3

18 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Region of HF Total Mixed Clinically PF Total PV Total PM Total Treated Total Treated Benshangul-Gumuz Sum, ,8 N 2 % 9% 8% % % 9% SNNPR Sum 77,84 25,49 33, ,884 N % 43% 57% % % 23% Grand Total Sum 247,46 56,242 46, ,528 4,393 N % 53% 43% % 4% 57% Knowledge of Providers The assessment was also designed to determine the level of knowledge of the key technical personnel (i.e., prescribers, pharmacy staff, and laboratory staff) at HFs regarding malaria treatment and prevention. The responses to the questions posed will aid in planning further training and development of learning aids to improve rational prescribing, rational dispensing, and proper counseling all of which play a key role in achieving treatment goals and promoting better response to treatment. Responses considered correct are based on the Malaria Diagnosis and Treatment Guideline for Health Workers in Ethiopia (2nd edition, July 24). As shown in Table 6, the overall percentage of prescribers who replied correctly regarding the appropriate antimalarial drugs to recommend for different patients based on the specific malaria parasite and age/pregnancy condition is greater than that of dispensers both at hospitals and s. More than 98% and 8% of the prescribers and dispensers, respectively, knew the first line drugs recommended to treat malaria (PF, PV, and severe malaria). However, the percentages of prescribers and dispensers who correctly chose the right antimalarial drug for pregnant women and children <5 kg fell to 79% and 68%, respectively. These findings demonstrate a need to provide training and guidelines to ensure they possess this knowledge. Table 6: Knowledge of Providers Type of HF First-line Drug for Uncomplicated P. Falciparum First-line Drug for PV First-line Drug for Severe Malaria Drug for Pregnant Woman and Children <5 kg Drugs Recommended for Malaria Prophylaxis in Pregnant Women HL HL HL HL HL Count Prescribers % 95.7% % % 98% 95.7% 95.6% 82.7% 75.5% 4.3% 7.% Count Dispensers % 8.8% 84.% 68.2% 77.3% 9.9% 82.2% 59.% 76.% 5.3% 6.8% 4

19 Survey Findings and Analysis Staffing Status We obtained information on the staff categories and the extent of their qualifications in the pharmacy and laboratory units to determine staffing patterns and their adequacy to conduct and support the proper diagnosis, pharmaceutical supply and dispensing, and counseling services at their facilities. Table 7: Pharmacy Staff at and Type of HF Region of the HF Pharmacist Druggist Pharmacy technician Pharmacy clerk Tigray (n=3) 3 4 Harari (n=) Dire Dawa (n=) Afar (n=) 3.. Amhara (n=5) Somali (n=) Benshangul-Gumuz (n=2) SNNPR (n=7) Sum Tigray (n=6) 9 3 Harari (n=) 2 Dire Dawa (n=4) 9. Afar (n=2) 5. Amhara (n=6) 37 8 Somali (n=2) 3.. Benshangul-Gumuz (n=5) SNNPR (n=) Sum Grand Total In general, the assessment team found there were 83 pharmacists, and 57 druggists and pharmacy technicians in the 2 assessed hospitals (Table 7). On the other hand, we found pharmacists, 287 druggists and pharmacy technicians, and 35 data clerks in the assessed 46 s. Product Availability A total of 3 key tracer medicines and other products (of which approximately 29% are laboratory products) used in malaria, TB, and HIV/OI management were selected for assessing availability and expiry. The assessment revealed that the overall availability of AMDs is 83% at hospitals and 74% at s. The availability of an AMD (chloroquine) for treating PV malaria is better than that for PF malaria (artemether-lumefantrine, or AL) both at hospitals and s. The availability of chloroquine is 78% and 72%, at hospitals and s, respectively, while the availability of AL is 9% and 83%, respectively. Quinine tablets, which are recommended for treatment of uncomplicated PF malaria in pregnant women during the first trimester and in children under 5kg, are not available at 3% 5

20 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment of the hospitals and 35% of the s, which requires improvement. Although the reason why HFs are stocking sulfadoxine-pyrimethamine (SP) was not included in the questionnaire, it was available at more than 2% of the hospitals and 245 of the s (Table 8). Due to resistance to malaria parasites, SP is not recommended for treatment of malaria in Ethiopia. Table 8. Availability of Antimalaria Product at the Time of Visit HF SP AL 6 AL 2 AL 8 AL 24 N % N % 5 2.7% 24.% 2 87.% % 9 74.% % % % 9 74.% % Chloroqu Tab 2 9.3% % Chloroqu Syr 7 74.% % Quinine Tab 2 87.% % Quinine Inj % % Stock-Out Days for AMDs The number of stock-out days for products used to treat malaria is higher at hospitals than at s. The average number of stock-out days for chloroquine syrup (>9) is highest at hospitals while that of quinine tablets (>23) is highest at s. RDTs are not expected to be available at hospitals since they are not recommended at s and hospitals (Table 9). However, since s are the source of supply of RDTs and other medicines for health posts, they should not have experienced stock-outs of RDTs. This situation requires attention and improvement. Table 9. Stock-Out Days for AMDs at HFs AL Chloroqu Quinine HF SP Tab Syr Tab Inj RDT Sum Avg N Sum Avg N Expiry of Malaria Medicines in Assessed HFs Overall the availability of expired AMDs at the HFs assessed is very low. Other than a few hospitals and s in Amhara and a limited number of s in Diredawa, other regions have experienced a very low expiry of AMDs. However, the quantities of AL and quinine tablets that expired at HFs are more than the others and are significant. With weak record keeping and stock status tracking, and congested storage, the presence of expired products that have not been disposed of alongside active products gives an incorrect impression of having stock. Active inventory management and disposal of unusable products are key interventions that lay the foundation for ensuring reliable information for forecasting need and efficient management of space. 6

21 Survey Findings and Analysis Table 2. Expired Quantities of AMDs HF Region SP AL 6 Dire Dawa N Afar N Amhara 98 N Benshangul- Gumuz N SNNPR N Tigray 2 N Dire Dawa 45 N Afar N Amhara 6 N 2 SNNPR 6 N AL AL AL Chloroqu Tab Chloroqu Syr 6 Quinine Tab Quinine Inj 2 TB Medicines Availability The overall availability of TB medicines at the surveyed HFs is at least 75%. Further, 7% of hospitals and 58% of s stated that they have TB drugs while the other facilities reported stock-outs. However, compared to other TB drugs, availability of the four-drug combination rifampicin, isoniazid, pyrazinamide, and ethambutol (RHZE) is the highest both at hospitals and s. (table 2). These findings illustrate the need for increased TB drugs availability at HFs in these regions. Table 2. Availability of TB Medicines at the Time of Visit Type of HF RHZE 5/75/4/27 5 mg RH 5/75 mg Ethambutol 4 mg INH mg and 3 mg Streptomycin g Determine/ KHB N % 9.3% 87% 56.5% 65.2% 56.5% 69.5% N % 7.7% 7.7% 28.3% 6.8% 45.6% 67.4% Availability of HIV/OI Medicines: Stock-Out Days for Antiretroviral Drugs at HFs Overall, stock-outs of antiretroviral (ARV)/OI medicines are higher at s than hospitals. Stock-out of stavudine is greater at both s and hospitals than it is for other ARV medicines, and stock-out of fluconazole is greater than it is for other OI medicines. 7

22 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Table 22. Stock-Out Days for ARV Drugs at HFs HF Sum Avg. N Sum Avg. N Lamivudine 3 mg/ Zidovudine 6 mg Tab Lamivudine 5 mg Tab Stavudine 5 mg Caps Efavirenz 5 mg Caps Nevirapine mg/ml Sus Fluconazole Tab Co-trimoxazole Tab Ciprofloxacin Tab Table 23. Availability of Laboratory Reagent and Tools at the Time of Visit Facility RDT Geimsa stain Methanol Acetone Glycerin Denatured Oil Immersion Oil Binocular Microscope Microscope Objective (x) N % 4.3% 74% 48% 56.5% 43.5% 78.3% 82.6% 65.2% 39% N % 35% 65.2% 56.5% 4.3% 32.6% 65.2% 85% 69.5% 37% 8

23 Survey Findings and Analysis Laboratory Commodities Availability To assess the availability of laboratory-related products, the team used nine tracer products including microscopes. The findings indicate that availability of key laboratory-related products and supplies for microscopic malaria diagnosis is low both at hospitals and s. For example, Geimsa stain was available at 74% of the hospitals and only 65% of the s, demonstrating an inadequate supply of this reagent to diagnose malaria patients. Similarly, not all hospitals (65%) and s (69%) have binocular microscopes. Only 39% of the hospitals have microscope objectives suitable for differentiating species (x objective), and just over 82% have immersion oil (Table 23). Storage and Store Accessories Key indicators considered in assessing storage and handling of medicines include availability of shelves, pallets, refrigerators, organized storage, segregation and disposal of expired or obsolete products, and incidence of theft or loss. Medicines must be handled properly and stored under the right conditions, expired medicines must be disposed of properly, and security must be maintained. Medicines that are not properly handled will be adversely affected, and their effectiveness and safety will be compromised to a degree that they either will not help the patient or may bring harm to the patient. Because medicines are extremely sensitive products that can easily be affected and lose their medical properties, findings of improper store management practices and lack of concern or required attention by management in the assessment is quite troubling. The assessment in general showed that the storage conditions at all levels are inadequate and do not meet professional standards. Many expired products congest the space, which could otherwise be used for storing useable products. About 38% of assessed s and 3% of the hospitals do not have good storage conditions. Only 54% of the hospitals and 3% of the s have adequate storage spaces for medicines, indicating that storage space improvement is needed. The overall segregation of expired drugs from active ones is very low in all regions but better at hospitals than at the s. 9

24 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Table 24. Storage Condition and Availability of Store Accessories Region of the HF Tigray Harari Dire Dawa Afar Amhara Somali Adequate Storage Space? Ceiling Intact? Carton/Box Packed Drugs Kept on Pallets? Away From Walls? Loose Packs Shelved? Expired Drugs Separated? % Good Storage Yes No Yes No Yes No Yes No Yes No Yes No Condition % 5% 5% % % 75% 25% 75% 25% % % 75% 25% % 5% 5% % % 5% 5% 5% 5% 67% 7% % % DHO 7% % % % % % % % % % % % % 5% % % % % % % % % % % % % 33% % % % % % % % % % % % % % % % % % % % % % % % % % % % 5% 5% 75% 25% 25% 75% 25% 75% % % % % % % % 5% 5% 5% 5% 5% 5% % % % % % % % % % 5% 5% % % 5% 5% % % DHO 7% % 4% 6% 8% 2% 8% 2% 6% 4% 8% 2% % % % 25% 75% 94% 6% 38% 63% 56% 44% 75% 25% % % DHO % 48% 83% % % % % % % % % % % % % 83% % % % % % % % % % % % % DHO 67% % % % % % % % % % % % % 2

25 Survey Findings and Analysis Region of the HF Benshangul- Gumuz SNNPR DHO DHO Adequate Storage Space? Ceiling Intact? Carton/Box Packed Drugs Kept on Pallets? Away From Walls? Loose Packs Shelved? Expired Drugs Separated? % Good Storage Yes No Yes No Yes No Yes No Yes No Yes No Condition 2 2 5% % % % % % % % 2% % % 2% % % 75% 25% 75% 25% % % 25% 75% 5% 5% % % % 5% 5% 25% 75% % % % % 25% 75% 25% 75% % 43% 57% 57% 43% 86% 4% 29% 7% 86% 4% 86% 4% % 4% 6% 7% 3% 3% 7% 4% 6% 9% % 9% % % % 9% 5% 5% % % % % 3% 7% 5% 2% 2

26 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Table 25: Region of the Health Facility * Expired Drugs Separated? Cross-tabulation Expired drugs separated? Yes No Unknown Total Tigray.%.%.%.% Afar.%.%.%.% Amhara % 47.8%.%.% Somali.%.%.%.% Benshangul-Gumuz % 75.%.%.% SNNPR % 2.% 3.%.% Total % 45.% 7.5%.% Table 26: HFs that Conducted Disposal of Obsolete/Unusable Malarial Drugs Tigray Harari Dire Dawa Afar Amhara Somali Benshangul- Gumuz SNNPR Region of the HF Obsolete/Unusable Malarial Drugs Disposed? Yes No 2 2 5% 6 % % % % 2 2 5% 2 % 2 % 4 8% % % % 5% 4 % 6 86% % 22

27 Survey Findings and Analysis Table 26 shows the degree of disposal of obsolete/unusable malarial or drugs at the targeted HFs in the regions surveyed. The disposal of obsolete/unusable malarial or drugs occurred in most of the facilities 88% of s and 8% of hospitals. However, the accumulation of unusable stocks of malaria commodities at the remaining facilities will present a challenge regarding storage space and a risk of being mistakenly dispensed to patients. This calls for immediate resolution. Table 27. Type of HF * RDT Stored at the Right Temperature? * Region of the HF Cross-Tabulation Region of the HF Tigray Harari Dire Dawa Afar Amhara Somali Benshangul-Gumuz SNNPR RDT Stored at the Right Temperature? Yes No Not Applicable As shown in Table 27 above, HFs in some regions are not storing RDTs in accordance with the required storage condition (temperature), which will affect the quality of the RDT and its results. These regions include Afar, Amhara, Benshangul-Gumuz, and SNNPR. Therefore, the storage condition of RDTs in HFs in these regions needs to be improved. 23

28 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Table 28. Availability of Storage Equipment Are Shelves Available? Is Wooden Pallet Available? Is Filling Cabinet Available? Is Computer Available? Is Refrigerator Available? Secure Door / Window Available? Region of the Health Facility Yes No Yes No Yes No Yes No Yes No Yes No Tigray % % 9% 3% % % 8% Harari % % 5% % 5% 5% % Dire Dawa % 8% 4% % 6% % 8% Afar % % % 25% 5% 5% 8% Amhara % 9% 57% 3% 76% 7% % Somali % % % 33% 33% 33% % Benshangul Gumuz % % 29% 29% 29% 43% 29% SNNPR % % 63% 4% 7% 82% 82% Overall % of Availability of Storage Equipment 83% 42% 6% 34% 7% 67% 43% 73% 24

29 Survey Findings and Analysis Proper store organization involving the appropriate storage equipment influences medicine quality, proper inventory management, and ease of moving around in the store. As shown in Table 28, 68% of the facilities have all the required storage equipment. Tigray facilities have the best (83%) storage equipment and Afar has the fewest HFs (34%) with the required storage equipment. Other regions need to improve the availability of storage equipment required for high-quality storage of medicines. Pharmaceutical Management Information System (PMIS) Availability of proper stock recording and inventory control tools and accurate and appropriate pharmaceutical management information are important prerequisites for a proper pharmaceutical supply management system (PSMS). All transactions should be properly recorded, processed, and reported to the next higher coordinating body for good planning in the supply management process. Stock cards, dispensing registers, and stock status monitoring forms are some of the essential tools required for maintaining proper stock control, tracking expired medicines, monitoring rational medicine use, ensuring adherence, and providing medicine consumption trends. The default inventory control (issuing and receiving) document present at all levels is the model an official government form that is used by all public sector institutions as a transaction document for commodities ranging from medicines to furniture to food items to stationery. However, the model template does not provide for the technical information required to manage pharmaceuticals. Use of the model has literally replaced the effective use of standard pharmaceutical forms such as stock cards as inventory control tools. To make the information system work, the appropriate technical forms must be available, correctly and promptly filled out, and aggregated for reporting. The assessment showed that inventory management tools are inadequate at all levels. For example, 62% of the hospitals and only 24% of the s have treatment/dispensing registers. However, all of the hospitals (%) and 96% of the s have bin cards. According to Table 29 below, an average of 7% of the s and 55% of the hospitals have updated their bin cards in all regions. This gap in malpractice requires intervention to improve current practice. 25

30 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment Table 29: Availability of PMIS Tools Tigray Harari Region of the HF Dire Dawa Afar Amhara Somali Are Treatment/Dispensing Registers Available? Is Ordering/ Requisition Form Available? Is Stock Card Available? Is Bin Card Available? Is Expiry/ Loss/Damage Report Form Available? Yes No Yes No Yes No Yes No Yes No % % 75% % 5% % 83% 67% 83% 33% % % % % % % % % % % % % % % % % 75% % % % % % % % % % % % % % % % % % 4% % % 27% 94% 9% % % % % %

31 Survey Findings and Analysis Region of the HF Beneshangul- Gumuz SNNPR Are Treatment/Dispensing Registers Available? Is Ordering/ Requisition Form Available? Is Stock Card Available? Is Bin Card Available? Is Expiry/ Loss/Damage Report Form Available? Yes No Yes No Yes No Yes No Yes No % % % % % % % % % 5% % 6% 5% % % % 86% 57% % 57% % 2% 9% 3% 27

32 SIAPS/PMI - AMDM Scale-Up Sites Baseline Assessment On average more than 63% of the hospitals and 94% of the s are updating their use of treatment registers. Overall, although the availability of PMIS tools such as bin cards and treatment registers are better at the hospitals, their use or updating is poor at hospitals compared to s. Table 3: Regular Use of PMIS Region of the HF Tigray Harari Dire Dawa Afar Amhara Somali Benshangul- Gumuz SNNPR Is Bin Card Updated? Is Stock Card Updated? Are Treatment/ Dispensing Registers Updated? Is Monthly Reporting Form Updated? Yes No Yes No Yes No Yes No % % % % % 25% % % % % % % % 3 75% 5% % 2 % % 4% % % 3 7 9% 75% % 88% % % % 2 2 % 5% % % % % % % % 75% 75% % % 5% 75% % 28

33 CONCLUSION AND RECOMMENDATIONS Availability and Expiry Management The assessment revealed that overall availability of AMDs is 83% at hospitals and 74% at s. However, some facilities reported stock-outs and shortages of the AMDs, including quinine tablets, for treatment of uncomplicated PF malaria in pregnant women during the first trimester and children under 5 kg. The shortages and stock-outs of medicines could arise as a result of several factors in the supply chain system. These include the use of a push system of distribution or improper quantification practices, which fail to address the HFs need for the medicines. A push system not only affects the availability of medicines but discourages the development of an active system of record-keeping, medication use monitoring, consumption-based ordering, and other more precise stock management procedures. The overall availability of expired AMDs at the HFs assessed was found to be very low except at a few hospitals and s. However, the quantities of AL and quinine tablets that expired at HFs are greater than the others, which is significant. Proper quantification and active inventory management at all levels of the supply chain system will help increase availability of medicines and reduce risk of expiry at the HFs. Therefore, it is advisable to establish and strengthen a system of good record keeping on the transactions made regarding medicines, including those dispensed to patients, to obtain reliable consumption data for resupply and quantification. In line with strengthening the supply chain system at all levels, regular stock rotation and the establishment of a uniform system for redistribution of excess and near expiry products will support efforts to reduce expiry and can contribute to improving availability at HFs. Finally, timely and safe disposal of unusable products will help to reduce risks to patients and free limited space occupied by these unusable products. Storage, Inventory Control, and Pharmaceutical Management Information System The assessment also determined that most of the HFs have shortages of basic storage equipment, such as pallets and shelves, as well as a limited amount of adequate storage space. This will negatively impact medicine quality, proper inventory management, and ease of moving around in the store. To solve these challenges, making available adequate pallets and shelves in addition to proper reorganization of the products within the available space will improve the storage conditions at the facilities and program level (Woreda and Zonal Health Office) medicine stores. Separation of non-drug items (such as office furniture, bicycles, and cement) from medicines and storing them in separate rooms will also free up space for medicine storage and contribute to maintaining the quality of medicines and avoiding damages. Proper inventory management tools at all levels will improve the accuracy and availability of appropriate pharmaceutical management information systems. The majority of the facilities assessed did not have a suitable tool such as dispensing registers for monitoring rational prescribing and dispensing practices at facilities. In addition, although the availability of stock transaction cards was encouraging, most of the HFs did not regularly update them. Without proper inventory and a patient and medication management system, ensuring uninterrupted supply; controlling pilferage and loss; monitoring expiry, medicine use, adverse 29